Chapter V
ORIGIN TRACING OF HERBAL MATERIALS, PREPARED TRADITIONAL MEDICINAL MATERIALS AND TRADITIONAL MEDICINES
Article 13. Written proofs of origin of herbal materials, prepared traditional medicinal materials and traditional medicines
1. A written proof of origin of herbal materials imported is a certificate of origin (C/O) of each batch of herbal materials issued by a state competent authority of the exporting country.
2. A written proof of origin of herbal materials cultivated, harvested or naturally extracted by a domestic establishment meeting the Good Agricultural and Collection Practices (GACP) requirements is a GACP-compliance certificate of such herbal materials.
3. A written proof of origin of herbal materials acquired by a trading establishment from domestic individuals cultivating, harvesting such herbal materials is a commitment to sites where such herbal materials are cultivated and harvested according to Form 07 in the Appendix I enclosed herewith.
4. A written proof of origin of a prepared traditional medicinal material includes:
a) Written proofs of origin of herbal materials used to process the traditional medicinal material;
b) A certificate of free sale for the prepared traditional medicinal material.
5. A written proof of origin of a traditional medicine includes:
a) Written proofs of origin of herbal materials used to process the traditional medicine;
b) A certificate of free sale for the traditional medicine.
Article 14. Archives of documents related to origin of herbal materials, prepared traditional medicinal materials and traditional medicines
1. A trading establishment must fully archive physical copies or soft copies of documents concerning each time of import and export of herbal materials, prepared traditional medicinal materials or traditional medicines with full accurate information as below:
a) Information on sellers and buyers of herbal materials, prepared traditional medicinal materials or traditional medicines: name, address, phone number and email (if any);
b) Information on herbal materials: common name, binomial name, used parts, origin and quality standards;
c) Information on prepared traditional medicinal materials: common name, processing method, binomial name, quality standards, batch number, date of manufacture, expiry date;
d) Information on traditional medicines: name, dosage form, content, batch number, date of manufacture, expiry date;
dd) Quantity of herbal materials, prepared traditional medicinal materials or traditional medicines imported and sold;
e) Date of importing herbal materials, prepared traditional medicinal materials or traditional medicines; date of selling herbal materials, prepared traditional medicinal materials or traditional medicines.
2. Each trading establishment of herbal materials must have a software of tracing origin of herbal materials.
3. Each manufacturer or importer that provide the distribution service or each wholesaler in charge of distribution must cooperate with other wholesalers or retailers in establishing a distribution system and adopting measures for monitoring and ensuring the origin traceability as well as monitoring the story and storage conditions of herbal materials, prepared traditional medicinal materials or traditional medicines.
4. Each trading establishment must archive dossiers and documents according to regulations specified in the Law on Archives, Decree guiding the Law on Archives and Circular No. 53/2017/TT-BYT dated December 29, 2017 of the Ministry of Health of Vietnam on deadlines for preservation of professional health dossiers or documents.
Tìm kiếm
Thông tư 38/2021/TT-BYT (Bản Pdf)
Thông tư 38/2021/TT-BYT (Bản Word)